Nighthawk 906000-0002

GUDID 00811714034423

Nighthawk Suture Anchor

RESPONSIVE ORTHOPEDICS LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00811714034423
• NIH Device Record Key: 29a2f0b9-2df8-41fd-87a9-d74007e459a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nighthawk
• Version Model Number: 906000-0002
• Catalog Number: 906000-0002
• Company DUNS: 002745858
• Company Name: RESPONSIVE ORTHOPEDICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811714034423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190446

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [Nighthawk]

• 00811714030289: Nighthawk Suture Anchor Short
• 00811714030265: Nighthawk Suture Anchor Long
• 00811714034430: Nighthawk Suture Anchor
• 00811714034423: Nighthawk Suture Anchor
• 00811714034720: Nighthawk Standard Step Drill Long
• 00811714034713: Nighthawk Standard Step Drill Medium
• 00811714034706: Nighthawk Hard Bone Drill Long
• 00811714034690: Nighthawk Hard Bone Drill Medium
• 00811714034683: Nighthawk Standard Drill Long
• 00811714034676: Nighthawk Standard Drill Medium
• 00811714034621: Nighthawk Blunt Probe
• 00811714034607: Nighthawk Trocar Probe Long
• 00811714034591: Nighthawk Trocar Probe Medium
• 00811714034553: Nighthawk Guide Tube V-Mouth Long
• 00811714034546: Nighthawk Guide Tube V-Mouth Medium
• 00811714034515: Nighthawk Guide Tube Crown Long
• 00811714034508: Nighthawk Guide Tube Crown Medium
• 00811714032726: Nighthawk Long Instrument Set
• 00811714032719: Nighthawk Medium Instrument Set